Version 2 - Date:06/09/2021 - STH20788 - IRAS:274410
Thank you for taking the time to consider taking part in this research project. This research project will contribute to a student’s PhD at The University of Sheffield.
Before you decide to take part it is important for you to understand why this research is being done and what it will involve.
This information sheet tells you about the project. Please read this sheet carefully and ask us if there is anything that is not clear or if you would like more information. This research is confidential, and your anonymity will be protected at all times.
There are different causes of transient loss of consciousness (TLOC) which need to be treated in different ways. The aim of this study is to find out whether it is possible to use a ‘digital doctor’ to make diagnoses in people who have presented to medical services with TLOC. The ‘digital doctor’ is a talking head presented on a computer screen which will ask you questions about what happened, just like a human doctor would. If a witness of the event(s) in which you lost consciousness is available, the ‘digital doctor’ will also ask questions of this observer. You can speak to the ‘digital doctor’ just like you would speak to a human doctor. Your answers will be recorded by the computer and analysed automatically. When our research has been completed, we hope that the digital doctor will be able to decide what the most likely cause of your episode(s) of TLOC was.
The purpose of this study is to train the ‘digital doctor’ using the responses of patients (and witnesses if available) to questions about your experience of TLOC and the diagnosis that you have received from your doctor. The ‘digital doctor’ will not be used to provide a diagnosis for you, and you will not be informed of any predictions that the ‘digital doctor’ makes based on your individual responses. The ‘digital doctor’ will not influence your investigations or treatments that you are currently having or will have in the future in any way. It can be difficult to identify why a person has experienced an episode of TLOC, which can delay the moment when they receive the correct treatment. We hope that the method used in this study will eventually help doctors to diagnose patients presenting with TLOC more quickly and accurately.
You have been asked to take part because you have experienced TLOC and have previously received a diagnosis from a specialist in the past.
No, it is entirely up to you. This information sheet should help you to decide, and we are happy to answer any questions. If you do decide to take part, you will be asked to sign a consent form. You can withdraw from the study at any time without having to give a reason. The decision to leave the study or a decision not to take part will not affect the standard of care that you receive.
If you decide that you are happy to take part in this study, we would initially ask you to consider whether a witness of your episode(s) of TLOC would be interested in participating to provide additional information about your episodes. If so, we would be grateful if you could show them the information sheet for TLOC witnesses.
If you tell us that you would like to take part in this study, a member of our research team will arrange for you (and a witness if available) to speak to the computer-presented ‘digital doctor’ by sending you a link to access the procedure on your computer or laptop at home. To access the ‘digital doctor’ at home, you will need either a laptop or tablet that has a camera and microphone. It should not take more than 20 minutes to talk to the digital doctor. You will be able to answer some of the questions asked by the ‘digital doctor’ by speaking to the computer. Other questions will be written on the computer screen and will require you to click on the response you wish to give. The way you speak to the computer will be audio- and video-recorded through the camera and microphone built into the computer. Taking part in our procedure will not impact your current or future medical care.
All participants will be given the opportunity to provide feedback on the ‘digital doctor’ either by completing a questionnaire at the end of the procedure, being interviewed, or both. You do not have to provide feedback on the ‘digital doctor’ and this will not influence your eligibility to engage in the first part of the experiment. We will ask participants to specify if they want to provide feedback at the start of the experiment and how you wish to provide feedback. If you are willing to complete the questionnaire, the questionnaire will appear after you finish speaking with the ‘digital doctor’. If you are willing to be interviewed, we could carry out your interview over the telephone or schedule a time after your appointment to answer questions about your experience in person.
Now you should consider whether you would like to take part in the study and if there was a witness to your episode(s) of TLOC who may be able and willing to provide additional information to the ‘digital doctor’. If so, please share the Participant Information Sheet for witnesses with this person and ask them whether they would be happy to take part. Please remember that you would still be able to take part in the study if there was not a witness of the episode(s) who may want to take part.
There is a link to our website included on the research summary. This link will take you to our ‘consent-to-contact’ form. The information that you provide on the form will be shared with a member of our research team who will use it to contact you about the research project. If you are interested in taking part in the research or wish to speak with the research team about the project, please complete the form. A member of the research team will then contact you to discuss the project and answer any outstanding questions.
If you want to take part, we will also ask you (and any witness) to complete an electronic consent form before you speak with the ‘digital doctor’.
This study will help researchers at Sheffield Teaching Hospitals and the University of Sheffield to produce a better computer that can interact and ask questions of people with seizures.
This research aims to investigate whether people’s responses to a ‘digital doctor’ can be used to diagnose different causes of TLOC. If the procedure works, we hope that this research will benefit patients presenting with transient loss of consciousness in the future because patients will be more likely to receive the right treatment more quickly. As the procedure is currently being researched, we will not be able to share the predicted diagnosis with you as there is no certainty of the accuracy of the output.
Individuals who participate in the research project will be entered into a raffle to win a £10 amazon voucher. The raffle will repeat monthly. Participants will be entered into the raffle on the month that they complete the study procedure. The raffle will be drawn at the end of the month and the winner will receive the amazon voucher by email.
Engaging with the ‘digital doctor’ will take 20 minutes. If you wish to provide feedback on the ‘digital doctor’ by interview, the telephone interview may take another 20 minutes.
If you or your witness do not feel comfortable using the digital doctor at any point, you are free to withdraw and do not have to complete the interaction. If you have consented to your data being analysed if you withdraw from the study, any data already collected by the digital doctor within the interaction will be used within the analysis.
The findings from this study will test whether the procedure can be used to accurately identify the cause of TLOC. The feedback from people who take part in the second part of the study to provide feedback on the digital doctor will allow us to improve the procedure. The results of the study will be published in scientific journals. We may use direct quotes from your interaction with the digital doctor in the papers to be published; however, these will be anonymous, you will not be identified in any publication and you can specify whether you want this to happen or not when you give consent to take part. It usually takes one or two years before the results of a study like this will be published.
You can withdraw from the study at any time without your standard of care being affected in any way.
If you have a concern about any aspect of this study, you should ask to speak to the study coordinator in the first instance who will do their best to answer your questions (Nathan Pevy, 07726578705; email@example.com or Professor Markus Reuber, 0114 2268763).
All information collected about you during the course of the research will be kept strictly confidential unless we are required to disclose the information by law, for example if there is a risk of harm to yourself or another person.
The audio and video data collected in the study will be securely stored on a University of Sheffield server. A member of the research team will create a transcript of what you say to the 'digital doctor'. Anything that you say that could be used to identify you (for example your name) will be removed and replaced with a pseudonym on the transcript. The video and audio data will not be anonymised but will be stored securely on a password encrypted university owned computer and only members of the research team will have access to the data unless you specify otherwise. The research team will use the transcript and video/audio recording to identify patterns in patient and witness descriptions that may help to predict the underlying diagnosis. We will then investigate whether these patterns can be automatically detected by a computer using the audio/video files. The data will remain secure during this analysis.
We will ask you on the consent form whether you give us permission to use the audio or video recordings collected in the research project for future teaching and training purposes. You will also be asked whether we can use the audio/video recordings in future research projects. This is optional and we will only use the data in this way if you give us permission. If you choose to allow us to use your video/audio data in future research or teaching, researchers working with the data or students/ staff attending the training will be able to identify you. If you specify that you do not want us to use your data for future research or for training purposes, your data will be destroyed after 15 years. Data will then be erased from all computer storage facilities according to the standard university procedures in place at the time for deleting and handling confidential, digital data.
You will also be asked on the consent form whether short quotes from the transcript can be included in research publications. These quotes would be anonymized and your personal data will be removed so that you cannot be identified.
Sheffield Teaching Hospital NHSFT (STH NHSFT) is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. STH NHSFT will keep identifiable information about you until the study finishes, with the exception of consent forms which will be stored according to Good Clinical Practice. STH NHSFT will then archive the study anonymously for a minimum of 15 years. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible. You can find out more about how we use your information at https://www.sth.nhs.uk/about-us/general-data-protection-regulations and https://www.sheffieldclinicalresearch.org/for-patients-public/how-is-your-information-handled-in-research/
All information collected during this study will be kept confidential. However, authorised representatives from the hospital research office or UK regulatory authorities might perform an audit of the trial and review the trial data and your medical records. STH NHSFT will use your name and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from STH NHSFT and regulatory organisations may look at your research records to check the accuracy of the research study. The only people in STH NHSFT who will have access to information that identifies you will be people who need to contact you for the trial or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.
The research is part of a research project being conducted by Neurologists and researchers at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield. The research is funded by Epilepsy Research UK.
The study has been reviewed by the East Midlands- Leicester South ethics committee.
If you wish to find out further information please do not hesitate to contact the research team:
Professor Markus Reuber